| Purpose: |
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This is a PI-initiated study taking place only at UCLA, sponsored by Sunovion. The
investigators plan to enroll about 20 subjects who are at least 40 years old and have
Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the
effectiveness of Brovana and Serevent in helping relieve COPD symptoms. Specifically, the
investigators are looking at how much and for how long the two drugs can open up the small
airways in the lungs. This will be done with breathing tests on all subjects, and with high
resolution CT scans on subjects who agree to this optional part of the study. Half of
subjects will take Brovana (arformoterol tartrate inhalation solution) for 2 weeks and then
Serevent (salmeterol xinafoate inhalation powder) for 2 weeks; the other half will take
Serevent the first two weeks and Brovana the second two weeks. All subjects will also take
Spiriva (tiotropium) and will be provided with albuterol for immediate relief of symptoms.
After a Screening Visit to determine eligibility, subjects will be randomly assigned to
receive Brovana or Serevent for the first 2 weeks, complete Test Visit 1, then receive the
other study drug for 2 weeks, and finally complete Test Visit 2. Visits will include
questionnaires, review of health and medications, and breathing tests before and after
taking the study drug. Subjects who agree to be in the sub-study will also undergo CT scans
before and after taking the study drug at both test visits.
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| Criteria: |
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Inclusion Criteria:
- Age >=40 years
- History of smoking >=20 pack-years of cigarettes
- Be using medically acceptable birth-control measures if a female of child-bearing
potential
- Be willing to withhold any existing short or long-acting bronchodilators for the
appropriate time period prior to each test day. Use of inhaled corticosteroids is not
exclusionary, but will be maintained at a constant level throughout the study.
- Must be willing and able to perform spirometry, slow vital capacity, plethysmography,
DLCO, and 6 minute walk after appropriate instruction.
- Informed consent
- At the screening visit:
- Post-albuterol FEV1/FVC <LLN (Hankinson)
- Post-albuterol FEV1 <70%% and >=30 % predicted (Hankinson)
- An increase in FEV1 after 4 puffs albuterol sulfate HFA of at least 5% and 50ml
Exclusion Criteria:
- Presence of other clinically significant illnesses or condition that might interfere
with the study, including but not limited to uncontrolled hypertension,
cardiovascular disease, cardiac arrhythmia, diabetes, hyperthyroidism, seizure
disorder or any history of pheochromocytoma
- History of asthma (in the opinion of the investigator)
- A COPD exacerbations within the past 2 months requiring oral corticosteroids or
hospitalization.
- Continuous oxygen therapy greater than 12 hours per day
- Subjects with a body mass index less than 15 or greater than 38
- Known allergy or contradiction to albuterol, arformoterol, salmeterol, tiotropium or
prior significant adverse reactions to other beta agonists or ipratropium.
- Hypersensitivity to milk protein. Bloating or gas from lactose is not an exclusion.
- Inability to withhold other adrenergic drugs (salmeterol, arformoterol, formoterol,
albuterol etc.) for an appropriate duration before each visit.
- Ongoing need for drugs which might potentiate hypokalemia (xanthine derivatives
(theophylline), steroids, non-potassium sparing diuretics (unless in fixed
combination with potassium sparing diuretic)
- Ongoing need for drugs which might cause QTc prolongation (MAO inhibitors, tricyclic
antidepressants, cardiac anti-arrhythmics Class Ia (e.g., disopyramide, procainamide,
quinidine), or class III (e.g., amiodarone, dofetilide, ibutilide, sotalol),
terfenadine, astemizole, mizolastin and any other drug with potential to
significantly prolong the QT interval.)
- Ongoing need for beta-blockers (selective or non-selective)
- Use of phenothizines (thioridizine), or other drugs that may interact with
arformoterol, salmeterol or albuterol for the duration of the study. Washout of
greater than seven half-lives of the drug prior to the study.
- History of angle closure glaucoma, symptomatic prostatic hypertrophy or bladder neck
obstruction.
- Investigational drugs within 30 days
- Affiliation with the Division of Pulmonary and Critical Care Medicine, David Geffen
School of Medicine
- Pregnancy, breastfeeding, planning to become pregnant during study, or woman of
childbearing potential unwilling to use adequate contraception
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